[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637729":3},{"organization":4,"armGroups":7,"interventions":34,"overallOfficials":40,"centralContacts":57,"locations":67,"responsibleParty":91,"collaborators":95,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":101,"sex":107,"minAge":108,"maxAge":40,"enrollmentInfo":109,"targetDuration":40,"studyType":112,"phases":113,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":123,"whyStopped":40,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"University Hospital Dubrava","OTHER",[8,14,19,24,29],{"label":9,"type":10,"description":11,"interventionNames":12},"PulseSelect PFA","ACTIVE_COMPARATOR","Participants randomized to this arm will undergo clinically indicated pulmonary vein isolation using the PulseSelect pulsed field ablation system. Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedure.",[13],"Device: Pulsed field ablation using PulseSelect system",{"label":15,"type":10,"description":16,"interventionNames":17},"Varipulse PFA","Participants randomized to this arm will undergo clinically indicated pulmonary vein isolation using the Varipulse pulsed field ablation system. Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedure.",[18],"Device: Pulsed field ablation using Varipulse system",{"label":20,"type":10,"description":21,"interventionNames":22},"Farapulse PFA","Participants randomized to this arm will undergo clinically indicated pulmonary vein isolation using the Farapulse pulsed field ablation system. Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedure.",[23],"Device: Pulsed field ablation using Farapulse system",{"label":25,"type":10,"description":26,"interventionNames":27},"Sphere-9 PFA","Participants randomized to this arm will undergo clinically indicated pulmonary vein isolation using the Sphere-9 pulsed field ablation system. Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedure.",[28],"Device: Pulsed field ablation using Sphere-9 system",{"label":30,"type":10,"description":31,"interventionNames":32},"Sphere-360 PFA","Participants randomized to this arm will undergo clinically indicated pulmonary vein isolation using the Sphere-360 pulsed field ablation system. Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedure",[33],"Device: Pulsed field ablation using Sphere-360 system",[35,41,45,49,53],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"DEVICE","Pulsed field ablation using PulseSelect system","Pulmonary vein isolation will be performed using the PulseSelect pulsed field ablation system in patients with paroxysmal or persistent atrial fibrillation undergoing clinically indicated catheter ablation. Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedure.",[9],null,{"type":36,"name":42,"description":43,"armGroupLabels":44,"otherNames":40},"Pulsed field ablation using Varipulse system","Pulmonary vein isolation will be performed using the Varipulse pulsed field ablation system in patients with paroxysmal or persistent atrial fibrillation undergoing clinically indicated catheter ablation. Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedure.",[15],{"type":36,"name":46,"description":47,"armGroupLabels":48,"otherNames":40},"Pulsed field ablation using Farapulse system","Pulmonary vein isolation will be performed using the Farapulse pulsed field ablation system in patients with paroxysmal or persistent atrial fibrillation undergoing clinically indicated catheter ablation. Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedu",[20],{"type":36,"name":50,"description":51,"armGroupLabels":52,"otherNames":40},"Pulsed field ablation using Sphere-9 system","Pulmonary vein isolation will be performed using the Sphere-9 pulsed field ablation system in patients with paroxysmal or persistent atrial fibrillation undergoing clinically indicated catheter ablation. Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedure.",[25],{"type":36,"name":54,"description":55,"armGroupLabels":56,"otherNames":40},"Pulsed field ablation using Sphere-360 system","Pulmonary vein isolation will be performed using the Sphere-360 pulsed field ablation system in patients with paroxysmal or persistent atrial fibrillation undergoing clinically indicated catheter ablation. Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedure",[30],[58,63],{"name":59,"role":60,"phone":61,"phoneExt":40,"email":62},"Ivan Zeljković, PhD,MD","CONTACT","+385917823289","ivanzeljkov@gmail.com",{"name":64,"role":60,"phone":65,"phoneExt":40,"email":66},"Mihovil Santini, MD","+385958101778","023miho@gmail.com",[68,86],{"facility":69,"status":40,"city":70,"state":40,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"UH Dubrava","Zagreb","10000","Croatia","HR",{"type":75,"coordinates":76},"Point",[77,78],15.97798,45.81444,{"lat":78,"lon":77},[81,84],{"name":82,"role":83,"phone":40,"phoneExt":40,"email":40},"Ivan Zeljković, MD, Phd","PRINCIPAL_INVESTIGATOR",{"name":64,"role":85,"phone":40,"phoneExt":40,"email":40},"SUB_INVESTIGATOR",{"facility":87,"status":40,"city":70,"state":40,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":88,"geoPoint":90,"contacts":40},"University Hospital Center Sisters of Charity, Zagreb, Croatia",{"type":75,"coordinates":89},[77,78],{"lat":78,"lon":77},{"type":92,"investigatorFullName":93,"investigatorTitle":94,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"SPONSOR_INVESTIGATOR","Ivan Zeljkovic","Principal Investigator and Head of Diagnostic and Therapeutic Department for Cardiac Electrostimulation and Electrophysiology",[96,97],{"name":5,"class":6},{"name":87,"class":98},"UNKNOWN","100637729","cerebral-microembolization-during-pulmonary-vein-isolation-comparison-of-different-pulsed-field-ablation-systems-100637729",false,"NCT07610018","Cerebral Microembolization During Pulmonary Vein Isolation: Comparison of Different Pulsed Field Ablation Systems","Cerebral Microembolization During Pulmonary Vein Isolation: a Randomized Comparison of Different Pulsed Field Ablation Systems","MICROPFA","Inclusion Criteria:\n\n* Age 18 years or older\n* Paroxysmal or persistent atrial fibrillation\n* Indication for catheter ablation with pulmonary vein isolation\n* Feasibility of transcranial Doppler assessment\n* Signed informed consent\n\nExclusion Criteria:\n\n* Recent stroke or transient ischemic attack\n* Significant cerebrovascular disease preventing reliable transcranial Doppler assessment\n* Severe valvular or structural heart disease\n* Pregnancy or breastfeeding\n* Inability to receive anticoagulation","ALL","18 Years",{"count":110,"type":111},100,"ESTIMATED","INTERVENTIONAL",[114],"NA","This prospective, randomized, parallel-group interventional study will compare cerebral microembolization during pulmonary vein isolation between different pulsed field ablation systems in patients with paroxysmal or persistent atrial fibrillation. Adult patients with an indication for catheter ablation will be randomized to one of the included ablation systems: PulseSelect, Varipulse, Farapulse, Sphere-9, or Sphere-360. Microembolic signals will be assessed using transcranial Doppler before and after the procedure. The primary outcome will be the difference in the change in microembolic signal burden, expressed as ΔMES, between the different ablation systems.",[117],"Ablation of Arrhythmia's",[119,120,121,122],"Atrial fibrillation","Pulmonary vein isolation","Cerebral microembolization","Pulsed field ablation","NOT_YET_RECRUITING","2026-05-21",{"date":126,"type":127},"2026-05-27","ACTUAL",{"date":129,"type":111},"2026-06-01",{"date":131,"type":111},"2027-01-20",{"name":93,"class":6},2]